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Neurotoxin

A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines

Phase 2
Waitlist Available
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 270

Summary

This trial tests a type of Botox on adults with noticeable frown lines. It aims to see if it safely and effectively reduces these wrinkles by relaxing forehead muscles.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 270
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 270 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Adverse Events (AEs)
Percentage of Participants with Achievement of ≥ 1-grade improvement from baseline as rated by investigator using the Clinician Glabellar Lines Scale.
Secondary study objectives
Percentage of Participants with Achievement of None or Mild as rated by investigator using the Clinician Glabellar Lines Scale.
Percentage of Participants with Achievement of improvement per the Facial Lines Satisfaction Questionnaire Impact domain, among subjects with baseline scores of 14 points or greater.
Percentage of Participants with Achievement of satisfaction with treatment per the Facial Line Satisfaction Questionnaire Item 5.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: OnabotulinumtoxinA X Dose CExperimental Treatment1 Intervention
OnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1.
Group II: OnabotulinumtoxinA X Dose BExperimental Treatment1 Intervention
OnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1.
Group III: OnabotulinumtoxinA X Dose AExperimental Treatment1 Intervention
OnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1.
Group IV: PlaceboPlacebo Group1 Intervention
Placebo will be injected into the Glabellar Complex on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OnabotulinumtoxinA X
2021
Completed Phase 2
~460

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Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
276,357 Total Patients Enrolled
1 Trials studying Frown Lines
101 Patients Enrolled for Frown Lines
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
79,247 Total Patients Enrolled
~79 spots leftby Dec 2025
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